Comparison of patient state index and bispectral index for sevoflurane consumption and end tidal sevoflurane consumption in patients undergoing laparoscopic surgical and gynaecological procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To determine the volume of sevoflurane consumed (in ml) in patients, while monitoring depth of anaesthesia using Bispectral Index versus Patient State Index
Study Overview
Brief Summary
Accurate monitoring of anaesthetic depth is essential for optimizing drug delivery, ensuring patient
safety, preventing awareness during anaesthesia and enhancing recovery outcomes and reducing cost during surgical
procedures. In laparoscopic surgical and gynaecological procedures , where optimal anaesthetic dose and rapid
emergence are desirable, the use of brain-function monitors can guide more precise titration of
volatile anaesthetic agents such as sevoflurane.This achieves more significance in ASA 3 and 4 patients where
optimal anesthetic dose will reduce adverse effects.
Two widely used parameters - the Bispectral Index (BIS) and the **Patient State Index (PSI)-**offer real-time
assessment of a patient’s level of consciousness based on processed EEG data. While both aim to
prevent intraoperative awareness and reduce anaesthetic consumption, they rely on different proprietary algorithms
and EEG interpretations. BIS analyzes EEG bispectral and power spectral data, while PSI incorporates bilateral EEG
coherence and anterior-posterior phase relationships.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA 1-2 Scheduled for Laparoscopic gynaecological/surgical procedures.
Exclusion Criteria
- •Known neurological disorders combined regional- general anaesthesia pregnant or lactating women Patient refusal.
Outcomes
Primary Outcomes
To determine the volume of sevoflurane consumed (in ml) in patients, while monitoring depth of anaesthesia using Bispectral Index versus Patient State Index
Time Frame: Baseline- Time of intubation,5mins,10mins,15mins,20mins,25mins,30mins,35 mins,40mins,45 mins,50mins,55mins,60mins | Post one hour of intubation -every 15mins till the end of surgery
Secondary Outcomes
- -To assess the end-tidal sevoflurane concentration (ETSevo) during surgery in both groups(-To compare recovery profiles including time to extubation & response to verbal commands between the two groups.)
Investigators
Dr Rangalakshmi S
RajaRajeswari Medical College and Hospital 202 Kambipura Mysore Road Bangalore